25 March 2016 Electronic data capture and DICOM data management in multi-center clinical trials
Author Affiliations +
Abstract
Providing eligibility, efficacy and security evaluation by quantitative and qualitative disease findings, medical imaging has become increasingly important in clinical trials. Here, subject’s data is today captured in electronic case reports forms (eCRFs), which are offered by electronic data capture (EDC) systems. However, integration of subject’s medical image data into eCRFs is insufficiently supported. Neither integration of subject’s digital imaging and communications in medicine (DICOM) data, nor communication with picture archiving and communication systems (PACS), is possible. This aggravates the workflow of the study personnel, in special regarding studies with distributed data capture in multiple sites. Hence, in this work, a system architecture is presented, which connects an EDC system, a PACS and a DICOM viewer via the web access to DICOM objects (WADO) protocol. The architecture is implemented using the open source tools OpenClinica, DCM4CHEE and Weasis. The eCRF forms the primary endpoint for the study personnel, where subject’s image data is stored and retrieved. Background communication with the PACS is completely hidden for the users. Data privacy and consistency is ensured by automatic de-identification and re-labelling of DICOM data with context information (e.g. study and subject identifiers), respectively. The system is exemplarily demonstrated in a clinical trial, where computer tomography (CT) data is de-centrally captured from the subjects and centrally read by a chief radiologists to decide on inclusion of the subjects in the trial. Errors, latency and costs in the EDC workflow are reduced, while, a research database is implicitly built up in the background.
© (2016) COPYRIGHT Society of Photo-Optical Instrumentation Engineers (SPIE). Downloading of the abstract is permitted for personal use only.
Daniel Haak, Daniel Haak, Charles-E. Page, Charles-E. Page, Thomas M. Deserno, Thomas M. Deserno, "Electronic data capture and DICOM data management in multi-center clinical trials", Proc. SPIE 9789, Medical Imaging 2016: PACS and Imaging Informatics: Next Generation and Innovations, 97890M (25 March 2016); doi: 10.1117/12.2218257; https://doi.org/10.1117/12.2218257
PROCEEDINGS
6 PAGES


SHARE
RELATED CONTENT

Early developments of PACS in Europe
Proceedings of SPIE (May 17 2000)
Constructing a secure HIPACS with structured reporting
Proceedings of SPIE (May 17 2000)
A proxy of DICOM services
Proceedings of SPIE (March 11 2010)

Back to Top